Monday, February 24, 2014

New China Fast-track Review Allows International Devices Accelerated Approval

New China Fast-track Review Allows International Devices Accelerated Approval-thegraysheet: China FDA released the finalized Special Review and Approval Procedure for Innovative Medical Devices Feb. 7, which allows both domestic and international device manufacturers to apply for accelerated approval, at least in theory. According to the regulation, China FDA promises early involvement, dedicated personnel and active communication with applicants, and a science-based review to speed up review time for qualified devices.

Thursday, February 20, 2014

Global View: Talking Harmonization And China With Just-Retired Commerce Official Jeffrey Gren

Global View: Talking Harmonization And China With Just-Retired Commerce Official Jeffrey Gren-thegraysheet: Few have more experience advocating for the U.S. device industry abroad than Jeffrey Gren, a former director at the U.S. Department of Commerce. During his 38-year stint at the department, from which he retired in January, Gren promoted U.S. device and drug exports and regulatory harmonization across countries, among other responsibilities.


Wednesday, February 19, 2014

POLITICO Magazine: The GOP alternative to Obamacare

POLITICO Magazine: The GOP alternative to Obamacare-politico: The Congressional Budget Office’s warning that the Affordable Care Act will cause employment to fall by the equivalent of 2.5 million full-time workers is just the latest of Obamacare’s negative surprises. Unfortunately, House Minority Leader Nancy Pelosi’s statement that “we have to pass the bill so that you can find out what is in it” is proving to be depressingly accurate.


Sebelius: ‘Absolutely no evidence’ of job losses under Obamacare

Sebelius: ‘Absolutely no evidence’ of job losses under Obamacare-washingtonpost: Secretary of Health and Human Services Kathleen Sebelius said Monday that there is zero evidence of job losses occurring as a result of the new federal health-care law. "There is absolutely no evidence -- and every economist will tell you this -- that there is any job loss related to the Affordable Care Act," Sebelius said in Orlando, according to video from WESH-TV. Sebelius added: "I know that's a popular myth that continues to be repeated, but it just is not accurate."

Most people say rating sites 'important' when picking doctors

Most people say rating sites 'important' when picking doctors-reuters:  When picking a new doctor, most people factor the reviews left on rating websites into their decision, according to a new study. Researchers found 59 percent of people said those physician-rating sites were at least "somewhat important" when choosing a doctor

Monday, February 17, 2014

Lee calls Obamacare delays a 'shameless power grab'

Lee calls Obamacare delays a 'shameless power grab'-politico: Sen. Mike Lee says President Barack Obama’s executive actions delaying portions of Obamacare are “shameless” acts done purely for political reasons.“This is a shameless act, a shameless power grab that is designed to help the president and his political party achieve a particular outcome in a partisan election,” the Utah Republican said on "Fox News Sunday."

Last call for state parties?

Last call for state parties?-politico: For many state parties, the party may soon be over. State party officials across the country say the explosion of money into super PACs, nonprofit groups and presidential campaigns has made fundraising more difficult. And some of those outside groups are starting to take over the traditional local roles state parties play, spending big on voter contact and outreach operations.